Δ9-THC Intoxication by Cannabidiol-Enriched Cannabis Extract in Two Children with Refractory Epilepsy: Full Remission after Switching to Purified Cannabidiol

Abstract

Animal studies and preliminary clinical trials have shown that cannabidiol (CBD)-enriched extracts may have beneficial effects for children with treatment-resistant epilepsy. However, these compounds are not yet registered as medicines by regulatory agencies. We describe the cases of two children with treatment-resistant epilepsy (Case A with left frontal dysplasia and Case B with Dravet Syndrome) with initial symptom improvement after the introduction of CBD extracts followed by seizure worsening after a short time. The children presented typical signs of intoxication by Δ9-THC (inappropriate laughter, ataxia, reduced attention, and eye redness) after using a CBD-enriched extract. The extract was replaced by the same dose of purified CBD with no Δ9-THC in both cases, which led to improvement in intoxication signs and seizure remission. These cases support pre-clinical and preliminary clinical evidence suggesting that CBD may be effective for some patients with epilepsy. Moreover, the cases highlight the need for randomized clinical trials using high-quality and reliable substances to ascertain the safety and efficacy of cannabinoids as medicines.

Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence

“…Sixteen studies reported AEs, 4 were RCTs25–28 and 12 were non-RCTs,11 12 31 32 35 45 48 49 51–54 including 3 self-report surveys,45 48 49 3 retrospective chart reviews,51 53 54 2 open-label trials,11 31 1 case study35 and 3 were a general observational design 12 32 52…”

Medicinal Properties of Cannabinoids, Terpenes, and Flavonoids in Cannabis, and Benefits in Migraine, Headache, and Pain: An Update on Current Evidence and Cannabis Science

“…There is medical evidence showing that CBD may be effective in treatment of a wide range of disorders including epilepsy (particularly medically‐refractory pediatric epilepsy syndromes), Alzheimer's disease, Parkinson's disease, MS, ‐ , Huntington's disease, ALS, anxiety disorders including PTSD, depression, dystonia, Meige's syndrome, schizophrenia and psychosis, stroke and hypoxic‐ischemic injury, antioxidant, TBI,…”

Quantification of Cannabinoids in Cannabis Oil Using GC/MS: Method Development, Validation, and Application to Commercially Available Preparations in Argentina

“…CBD appears not to have adverse consequences at high doses; however, Δ 9 -THC concentrations observed in cannabis oils (especially oil # 3, # 4, # 7, # 8) could be enough to produce intoxication, especially among children [39]. Interestingly, the web site from the CBD oil #4 producer reports a CBD/Δ 9 -THC ratio of 1:1, while we found a CBD/Δ 9 -THC ratio of 0.25:1.…”